Recital 38 Serial manufacturing, subsequent modifications and repairs


In order to ensure that products with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;, when placed on the market, do not pose cybersecurity risks means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; to persons and organisations, essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements should be set out for such products. Those essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements, including vulnerability means a weakness, susceptibility or flaw of a product with digital elements that can be exploited by a cyber threat; management handling requirements, apply to each individual product with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; when placed on the market, irrespective of whether the product with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; is manufactured as an individual unit or in series. For example, for a product type, each individual product with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; should have received all security patches or updates available to address relevant security issues when it is placed on the market. Where products with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; are subsequently modified, by physical or digital means, in a way that is not foreseen by the manufacturer means a natural or legal person who develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under its name or trademark, whether for payment, monetisation or free of charge; in the initial risk means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; assessment and that may imply that they no longer meet the relevant essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements, the modification should be considered to be substantial. For example, repairs could be assimilated to maintenance operations provided that they do not modify a product with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; already placed on the market in such a way that compliance with the applicable requirements may be affected, or that the intended purpose means the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation; for which the product has been assessed may be changed.

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